Sealing member for prosthetic heart valve

ABSTRACT

An implantable prosthetic valve can comprise an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, the frame defining an axial direction extending from the inflow end to the outflow end, a leaflet structure positioned within the frame and secured thereto, and an outer sealing member positioned around an outer surface of the frame, wherein the outer sealing member comprises a plurality of sealing segments, wherein each sealing segment is coupled to the frame and/or another sealing segment by a tether that pulls a portion of the sealing segment in a circumferential direction when the frame is radially expanded to the expanded configuration.

CROSS REFERENCE TO RELATED APPLICATION

This application is a divisional of U.S. application Ser. No.16/103,985, filed Aug. 16, 2018, which claims the benefit of U.S.Provisional Application Ser. No. 62/548,280, filed on Aug. 21, 2017,which applications are incorporated by reference herein.

FIELD

The present disclosure relates to implantable, expandable prostheticdevices and to methods and apparatuses for such prosthetic devices.

BACKGROUND

The human heart can suffer from various valvular diseases. Thesevalvular diseases can result in significant malfunctioning of the heartand ultimately require replacement of the native valve with anartificial valve. There are a number of known artificial valves and anumber of known methods of implanting these artificial valves in humans.Because of the drawbacks associated with conventional open-heartsurgery, percutaneous and minimally-invasive surgical approaches aregarnering intense attention. In one technique, a prosthetic valve isconfigured to be implanted in a much less invasive procedure by way ofcatheterization. For example, collapsible transcatheter prosthetic heartvalves can be crimped to a compressed state and percutaneouslyintroduced in the compressed state on a catheter and expanded to afunctional size at the desired position by balloon inflation or byutilization of a self-expanding frame or stent.

A prosthetic valve for use in such a procedure can include a radiallycollapsible and expandable frame to which leaflets of the prostheticvalve can be coupled, and which can be percutaneously introduced in acollapsed configuration on a catheter and expanded in the desiredposition by balloon inflation or by utilization of a self-expandingframe or stent. A challenge in catheter-implanted prosthetic valves iscontrol of perivalvular leakage around the valve, which can occur for aperiod of time following initial implantation. An additional challengeincludes the process of crimping such a prosthetic valve to a profilesuitable for percutaneous delivery to a patient.

SUMMARY

Embodiments of a radially collapsible and expandable prosthetic valveare disclosed herein that include an improved outer skirt for reducingperivalvular leakage, as well as related methods and apparatusesincluding such prosthetic valves. In several embodiments, the disclosedprosthetic valves are configured as replacement heart valves forimplantation into a patient.

In one representative embodiment, an implantable prosthetic heart valvecan include an annular frame, a leaflet structure positioned within theframe and secured thereto, and an annular outer skirt positioned aroundan outer surface of the frame. The frame can include an inflow end andan outflow end and can be radially collapsible and expandable between aradially collapsed configuration and a radially expanded configuration.The frame can define an axial direction extending from the inflow end tothe outflow end. The outer skirt can include an inflow edge portionsecured to the frame at a first location, an outflow edge portionsecured to the frame at a second location, an intermediate portionbetween the inflow edge portion and the outflow edge portion, and aplurality of tethers. The intermediate portion can include a pluralityof circumferentially spaced, axially extending slits that define aplurality of skirt segments between each pair of slits, and each skirtsegment can include first and second opposing edge portions. Each tethercan be secured to the first edge portion of a skirt segment at a firstend of the tether, can extend across the second edge portion of the sameskirt segment, and can be secured to the frame or an adjacent skirtsegment at a second end of the tether such that when the frame isexpanded to the radially expanded configuration, the first edge portionis pulled in a circumferential direction toward the second portion bythe tether.

In some embodiments, the second end of each tether can be secured to theframe.

In some embodiments, the second end of each tether can be secured to theframe at a location adjacent to the second edge portion of the skirtsegment that the first end of the tether is secured to.

In some embodiments, the frame can include a plurality of struts and thesecond end of each tether can be secured to the frame at a strutadjacent to the second edge portion of the skirt segment that the firstend of the tether is secured to.

In some embodiments, each tether can be positioned radially outside ofthe skirt segment.

In some embodiments, each tether can be positioned radially inside ofthe skirt segment.

In some embodiments, the tethers can comprise a first set of tetherspositioned radially outside of the skirt segment and a second set oftethers positioned radially inside of the skirt segment.

In some embodiments, the tethers can comprise a plurality of firsttethers and a plurality of second tethers. In such embodiments, eachfirst tether can have a first end secured to the first edge portion of arespective skirt segment, can extend across the second edge portion ofthe same skirt segment, and can have a second end secured to the frameat a first location. In such embodiments, each second tether can have afirst end secured to the second edge portion of a respective skirtsegment, can extend across the first edge portion of the same skirtsegment, and can have a second end secured to the frame at a secondlocation. In such embodiments, the first and second locations can beadjacent opposite sides of the skirt segment such that when the frame isexpanded to the radially expanded configuration, the second tether pullsthe second edge portion toward the first edge portion and the firsttether pulls the first edge portion toward the second edge portion.

In some embodiments, the first ethers can be positioned radially outsideof the outer skirt and the second tethers can be positioned radiallyinside of the outer skirt.

In some embodiments, the first ethers and the second tethers can each bepositioned radially outside of the outer skirt.

In some embodiments, the first tethers and the second tethers can eachbe positioned radially inside of the outer skirt.

In some embodiments, the second end of each tether can be secured to anadjacent skirt segment.

In some embodiments, the plurality of tethers can comprise a pluralityof first tethers and a plurality of second tethers. In such embodiments,each skirt segment can be coupled to a first adjacent skirt segment by arespective first tether and a second adjacent skirt segment by arespective second tether, such that when the frame is expanded to theradially expanded configuration, the first and second tethers pull thefirst and second edge portions of the skirt segment toward each other.

In some embodiments, for each skirt segment, a first tether can extendfrom the first edge portion of the skirt segment across the second edgeportion and can be secured to the first adjacent skirt segment, and asecond tether can extend from the second edge portion of the skirtsegment across the first edge portion, and can be secured to the secondadjacent skirt segment.

In some embodiments, the plurality of first tethers can be positionedradially inside of the outer skirt and the plurality of second tetherscan be positioned radially outside of the outer skirt.

In another representative embodiment, an implantable prosthetic valvecan include an annular frame, a leaflet structure positioned within theframe and secured thereto, and an outer sealing member positioned aroundan outer surface of the frame. The frame can include an inflow end andan outflow end and can be radially collapsible and expandable between aradially collapsed configuration and a radially expanded configuration.The frame can define an axial direction extending from the inflow end tothe outflow end. The outer sealing member can include a plurality ofsealing segments. Each sealing segment can be coupled to the frameand/or another sealing segment by a tether that pulls a portion of thesealing segment in a circumferential direction when the frame isradially expanded to the expanded configuration.

In some embodiments, each sealing segment can have upper and lowerportions connected to the frame at axially spaced apart locations on theframe that move toward each other upon radial expansion of the frame andcause a portion of the sealing segment to move radially outwardly awayfrom the frame.

In some embodiments, a width of each sealing segment in acircumferential direction can be reduced by a pulling force of a tetherconnected to the sealing segment upon radial expansion of the frame.

In some embodiments, each sealing segment can become at least partiallytwisted by a pulling force of a tether connected to the sealing segmentupon radial expansion of the frame.

In some embodiments, each tether can have one end secured to a sealingsegment and another end secured to the frame or another sealing segment.

The foregoing and other objects, features, and advantages of thedisclosure will become more apparent from the following detaileddescription, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-3 show an exemplary embodiment of a prosthetic heart valve.

FIGS. 4-10 show an exemplary frame of the prosthetic heart valve of FIG.1.

FIGS. 11-12 show an exemplary inner skirt of the prosthetic heart valveof FIG. 1.

FIG. 13 shows the prosthetic heart valve of FIG. 1 in a collapsedconfiguration and mounted on an exemplary balloon catheter.

FIGS. 14-16 show the assembly of the inner skirt of FIG. 11 with theframe of FIG. 4.

FIGS. 17-18 show the assembly of an exemplary leaflet structure.

FIG. 19 shows the assembly of commissure portions of the leafletstructure with window frame portions of the frame.

FIGS. 20-21 show the assembly of the leaflet structure with the innerskirt along a lower edge of the leaflets.

FIGS. 22-23 show various views of another exemplary outer skirt.

FIGS. 24-25 show an exemplary embodiment of a prosthetic heart valveframe using the outer skirt of FIGS. 22-23.

FIGS. 26-27 show another exemplary embodiment of a prosthetic heartvalve frame using the outer skirt of FIGS. 22-23.

FIGS. 28-29 show another exemplary embodiment of a prosthetic heartvalve frame using the outer skirt of FIGS. 22-23.

FIG. 30 shows an exemplary prosthetic heart valve implanted in thenative aortic valve of a patient.

FIG. 31 shows an exemplary prosthetic heart valve and docking deviceimplanted in the pulmonary artery of a patient.

FIG. 32 shows an exemplary prosthetic heart valve and docking deviceimplanted in the native mitral valve of a patient.

FIGS. 33-34 show an alternative embodiment of a docking device for aprosthetic valve.

FIG. 35 shows an exemplary prosthetic heart valve and the docking deviceof FIGS. 33-34.

DETAILED DESCRIPTION

FIGS. 1-3 show various views of a prosthetic heart valve 10, accordingto one embodiment. The illustrated prosthetic valve is adapted to beimplanted in the native aortic annulus, although in other embodiments itcan be adapted to be implanted in the other native annuluses of theheart (e.g., the pulmonary, mitral, and tricuspid valves). Theprosthetic valve can also be adapted to be implanted in other tubularorgans or passageways in the body. The prosthetic valve 10 can have fourmain components: a stent or frame 12, a valvular structure 14, an innerskirt 16, and a perivalvular sealing means or sealing member. Theprosthetic valve 10 can have an inflow end portion 15, an intermediateportion 17, and an outflow end portion 19. In the illustratedembodiment, the perivalvular sealing means comprises an outer skirt 18(which can also be referred to as an outer sealing member).

The valvular structure 14 can comprise three leaflets 41, collectivelyforming a leaflet structure, which can be arranged to collapse in atricuspid arrangement, as best shown in FIG. 2. The lower edge ofleaflet structure 14 desirably has an undulating, curved scalloped shape(suture line 154 shown in FIG. 21 tracks the scalloped shape of theleaflet structure). By forming the leaflets with this scallopedgeometry, stresses on the leaflets are reduced, which in turn improvesdurability of the prosthetic valve. Moreover, by virtue of the scallopedshape, folds and ripples at the belly of each leaflet (the centralregion of each leaflet), which can cause early calcification in thoseareas, can be eliminated or at least minimized. The scalloped geometryalso reduces the amount of tissue material used to form leafletstructure, thereby allowing a smaller, more even crimped profile at theinflow end of the prosthetic valve. The leaflets 41 can be formed ofpericardial tissue (e.g., bovine pericardial tissue), biocompatiblesynthetic materials, or various other suitable natural or syntheticmaterials as known in the art and described in U.S. Pat. No. 6,730,118,which is incorporated by reference in its entirety herein.

The bare frame 12 is shown in FIG. 4. The frame 12 can be formed with aplurality of circumferentially spaced slots, or commissure windows, 20(three in the illustrated embodiment) that are adapted to connect thecommissures of the valvular structure 14 to the frame, as described ingreater detail below. The frame 12 can be made of any of varioussuitable plastically-expandable materials (e.g., stainless steel, etc.)or self-expanding materials (e.g., nickel titanium alloy (NiTi), such asnitinol). When constructed of a plastically-expandable material, theframe 12 (and thus the prosthetic valve 10) can be crimped to a radiallycollapsed configuration on a delivery catheter and then expanded insidea patient by an inflatable balloon or equivalent expansion mechanism.When constructed of a self-expandable material, the frame 12 (and thusthe prosthetic valve 10) can be crimped to a radially collapsedconfiguration and restrained in the collapsed configuration by insertioninto a sheath or equivalent mechanism of a delivery catheter. Onceinside the body, the prosthetic valve can be advanced from the deliverysheath, which allows the prosthetic valve to expand to its functionalsize.

Suitable plastically-expandable materials that can be used to form theframe 12 include, without limitation, stainless steel, a biocompatible,high-strength alloys (e.g., a cobalt-chromium or anickel-cobalt-chromium alloys), polymers, or combinations thereof. Inparticular embodiments, frame 12 is made of anickel-cobalt-chromium-molybdenum alloy, such as MP35N® alloy (SPSTechnologies, Jenkintown, Pa.), which is equivalent to UNS R30035 alloy(covered by ASTM F562-02). MP35N® alloy/UNS R30035 alloy comprises 35%nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight. WhenMP35N® alloy is used as the frame material, as compared to stainlesssteel, less material is needed to achieve the same or better performancein radial and crush force resistance, fatigue resistances, and corrosionresistance. Moreover, since less material is required, the crimpedprofile of the frame can be reduced, thereby providing a lower profileprosthetic valve assembly for percutaneous delivery to the treatmentlocation in the body.

Referring to FIGS. 4 and 5, the frame 12 in the illustrated embodimentcomprises a first, lower row I of angled struts 22 arranged end-to-endand extending circumferentially at the inflow end of the frame; a secondrow II of circumferentially extending, angled struts 24; a third row IIIof circumferentially extending, angled struts 26; a fourth row IV ofcircumferentially extending, angled struts 28; and a fifth row V ofcircumferentially extending, angled struts 32 at the outflow end of theframe. A plurality of substantially straight axially extending struts 34can be used to interconnect the struts 22 of the first row I with thestruts 24 of the second row II. The fifth row V of angled struts 32 areconnected to the fourth row IV of angled struts 28 by a plurality ofaxially extending window frame portions 30 (which define the commissurewindows 20) and a plurality of axially extending struts 31. Each axialstrut 31 and each frame portion 30 extends from a location defined bythe convergence of the lower ends of two angled struts 32 to anotherlocation defined by the convergence of the upper ends of two angledstruts 28. FIGS. 6, 7, 8, 9, and 10 are enlarged views of the portionsof the frame 12 identified by letters A, B, C, D, and E, respectively,in FIG. 5.

Each commissure window frame portion 30 connects to a respectivecommissure of the leaflet structure 14. As can be seen each frameportion 30 is secured at its upper and lower ends to the adjacent rowsof struts to provide a robust configuration that enhances fatigueresistance under cyclic loading of the prosthetic valve compared tocantilevered struts for supporting the commissures of the leafletstructure. This configuration enables a reduction in the frame wallthickness to achieve a smaller crimped diameter of the prosthetic valve.In particular embodiments, the thickness T of the frame 12 (FIG. 4)measured between the inner diameter and outer diameter is about 0.48 mmor less.

The struts and frame portions of the frame collectively define aplurality of open cells of the frame. At the inflow end of the frame 12,struts 22, struts 24, and struts 34 define a lower row of cells definingopenings 36. The second, third, and fourth rows of struts 24, 26, and 28define two intermediate rows of cells defining openings 38. The fourthand fifth rows of struts 28 and 32, along with frame portions 30 andstruts 31, define an upper row of cells defining openings 40. Theopenings 40 are relatively large and are sized to allow portions of theleaflet structure 14 to protrude, or bulge, into and/or through theopenings 40 when the frame 12 is crimped in order to minimize thecrimping profile.

As best shown in FIG. 7, the lower end of the strut 31 is connected totwo struts 28 at a node or junction 44, and the upper end of the strut31 is connected to two struts 32 at a node or junction 46. The strut 31can have a thickness Si that is less than the thicknesses S2 of thejunctions 44, 46. The junctions 44, 46, along with junctions 64, preventfull closure of openings 40. FIG. 13 shows the prosthetic valve 10crimped on a balloon catheter. As can be seen, the geometry of thestruts 31, and junctions 44, 46, and 64 assists in creating enough spacein openings 40 in the collapsed configuration to allow portions of theprosthetic leaflets to protrude or bulge outwardly through openings.This allows the prosthetic valve to be crimped to a relatively smallerdiameter than if all of the leaflet material were constrained within thecrimped frame.

The frame 12 is configured to reduce, to prevent, or to minimizepossible over-expansion of the prosthetic valve at a predeterminedballoon pressure, especially at the outflow end portion of the frame,which supports the leaflet structure 14. In one aspect, the frame isconfigured to have relatively larger angles 42 a, 42 b, 42 c, 42 d, 42 ebetween struts, as shown in FIG. 5. The larger the angle, the greaterthe force required to open (expand) the frame. As such, the anglesbetween the struts of the frame can be selected to limit radialexpansion of the frame at a given opening pressure (e.g., inflationpressure of the balloon). In particular embodiments, these angles are atleast 110 degrees or greater when the frame is expanded to itsfunctional size, and even more particularly these angles are up to about120 degrees when the frame is expanded to its functional size.

In addition, the inflow and outflow ends of a frame generally tend toover-expand more so than the middle portion of the frame due to the“dog-boning” effect of the balloon used to expand the prosthetic valve.To protect against over-expansion of the leaflet structure 14, theleaflet structure desirably is secured to the frame 12 below the upperrow of struts 32, as best shown in FIG. 1. Thus, in the event that theoutflow end of the frame is over-expanded, the leaflet structure ispositioned at a level below where over-expansion is likely to occur,thereby protecting the leaflet structure from over-expansion.

In one type of prosthetic valve construction, portions of the leafletsprotrude longitudinally beyond the outflow end of the frame when theprosthetic valve is crimped if the leaflets are connected too close tothe distal end of the frame. If the delivery catheter on which thecrimped prosthetic valve is mounted includes a pushing mechanism or stopmember that pushes against or abuts the outflow end of the prostheticvalve (for example, to maintain the position of the crimped prostheticvalve on the delivery catheter), the pushing member or stop member candamage the portions of the exposed leaflets that extend beyond theoutflow end of the frame. Another benefit of connecting the leaflets ata location spaced away from the outflow end of the frame is that whenthe prosthetic valve is crimped on a delivery catheter, the outflow endof the frame 12 rather than the leaflets 41 is the proximal-mostcomponent of the prosthetic valve 10. As such, if the delivery catheterincludes a pushing mechanism or stop member that pushes against or abutsthe outflow end of the prosthetic valve, the pushing mechanism or stopmember contacts the outflow end of the frame, and not leaflets 41, so asto avoid damage to the leaflets.

Also, as can be seen in FIG. 5, the openings 36 of the lowermost row ofopenings in the frame are relatively larger than the openings 38 of thetwo intermediate rows of openings. This allows the frame, when crimped,to assume an overall tapered shape that tapers from a maximum diameterat the outflow end of the prosthetic valve to a minimum diameter at theinflow end of the prosthetic valve. When crimped, the frame 12 can havea reduced diameter region extending along a portion of the frameadjacent the inflow end of the frame that generally corresponds to theregion of the frame covered by the outer skirt 18. In some embodiments,the reduced diameter region is reduced compared to the diameter of theupper portion of the frame (which is not covered by the outer skirt)such that the outer skirt 18 does not increase the overall crimp profileof the prosthetic valve. When the prosthetic valve is deployed, theframe can expand to the generally cylindrical shape shown in FIG. 4. Inone example, the frame of a 26-mm prosthetic valve, when crimped, had afirst diameter of 14 French at the outflow end of the prosthetic valveand a second diameter of 12 French at the inflow end of the prostheticvalve.

The main functions of the inner skirt 16 are to assist in securing thevalvular structure 14 to the frame 12 and to assist in forming a goodseal between the prosthetic valve and the native annulus by blocking theflow of blood through the open cells of the frame 12 below the loweredge of the leaflets. The inner skirt 16 desirably comprises a tough,tear resistant material such as polyethylene terephthalate (PET),although various other synthetic materials or natural materials (e.g.,pericardial tissue) can be used. The thickness of the skirt desirably isless than about 0.15 mm (about 6 mil), and desirably less than about 0.1mm (about 4 mil), and even more desirably about 0.05 mm (about 2 mil).In particular embodiments, the skirt 16 can have a variable thickness,for example, the skirt can be thicker at least one of its edges than atits center. In one implementation, the skirt 16 can comprise a PET skirthaving a thickness of about 0.07 mm at its edges and about 0.06 mm atits center. The thinner skirt can provide for better crimpingperformances while still providing good sealing.

The skirt 16 can be secured to the inside of frame 12 via sutures 70, asshown in FIG. 21. Valvular structure 14 can be attached to the skirt viaone or more reinforcing strips 72 (which collectively can form asleeve), for example thin, PET reinforcing strips, discussed below,which enables a secure suturing and protects the pericardial tissue ofthe leaflet structure from tears. Valvular structure 14 can besandwiched between skirt 16 and the thin PET strips 72 as shown in FIG.20. Sutures 154, which secure the PET strip and the leaflet structure 14to skirt 16, can be any suitable suture, such as Ethibond Excel® PETsuture (Johnson & Johnson, New Brunswick, N.J.). Sutures 154 desirablytrack the curvature of the bottom edge of leaflet structure 14, asdescribed in more detail below.

Some fabric skirts comprise a weave of warp and weft fibers that extendperpendicularly to each other and with one set of the fibers extendinglongitudinally between the upper and lower edges of the skirt. When themetal frame to which such a fabric skirt is secured is radiallycompressed, the overall axial length of the frame increases. However, afabric skirt with limited elasticity cannot elongate along with theframe and therefore tends to deform the struts of the frame and toprevent uniform crimping.

Referring to FIG. 12, in one embodiment, the skirt 16 desirably is wovenfrom a first set of fibers, or yarns or strands, 78 and a second set offibers, or yarns or strands, 80, both of which are non-perpendicular tothe upper edge 82 and the lower edge 84 of the skirt. In particularembodiments, the first set of fibers 78 and the second set of fibers 80extend at angles of about 45 degrees (e.g., 15-75 degrees or 30-60degrees) relative to the upper and lower edges 82, 84. For example, theskirt 16 can be formed by weaving the fibers at 45 degree anglesrelative to the upper and lower edges of the fabric. Alternatively, theskirt 16 can be diagonally cut (cut on a bias) from a vertically wovenfabric (where the fibers extend perpendicularly to the edges of thematerial) such that the fibers extend at 45 degree angles relative tothe cut upper and lower edges of the skirt. As further shown in FIG. 12,the opposing short edges 86, 88 of the skirt desirably arenon-perpendicular to the upper and lower edges 82, 84. For example, theshort edges 86, 88 desirably extend at angles of about 45 degreesrelative to the upper and lower edges and therefore are aligned with thefirst set of fibers 78. Therefore the overall general shape of the skirtcan be that of a rhomboid or parallelogram.

FIGS. 14 and 15 show the inner skirt 16 after opposing short edgeportions 90, 92 have been sewn together to form the annular shape of theskirt. As shown, the edge portion 90 can be placed in an overlappingrelationship relative to the opposite edge portion 92, and the two edgeportions can be sewn together with a diagonally extending suture line 94that is parallel to short edges 86, 88. The upper edge portion of theinner skirt 16 can be formed with a plurality of projections 96 thatdefine an undulating shape that generally follows the shape or contourof the fourth row of struts 28 immediately adjacent the lower ends ofaxial struts 31. In this manner, as best shown in FIG. 16, the upperedge of the inner skirt 16 can be tightly secured to struts 28 withsutures 70. The inner skirt 16 can also be formed with slits 98 tofacilitate attachment of the skirt to the frame. Slits 98 can bedimensioned so as to allow an upper edge portion of the inner skirt 16to be partially wrapped around struts 28 and to reduce stresses in theskirt during the attachment procedure. For example, in the illustratedembodiment, the inner skirt 16 is placed on the inside of frame 12 andan upper edge portion of the skirt is wrapped around the upper surfacesof struts 28 and secured in place with sutures 70. Wrapping the upperedge portion of the inner skirt 16 around struts 28 in this mannerprovides for a stronger and more durable attachment of the skirt to theframe. The inner skirt 16 can also be secured to the first, second,and/or third rows of struts 22, 24, and 26, respectively, with sutures70.

Referring again to FIG. 12, due to the angled orientation of the fibersrelative to the upper and lower edges in this embodiment, the skirt canundergo greater elongation in the axial direction (i.e., in a directionfrom the upper edge 82 to the lower edge 84).

Thus, when the metal frame 12 is crimped (as shown in FIG. 13), theinner skirt 16 can elongate in the axial direction along with the frameand therefore provide a more uniform and predictable crimping profile.Each cell of the metal frame in the illustrated embodiment includes atleast four angled struts that rotate towards the axial direction oncrimping (e.g., the angled struts become more aligned with the length ofthe frame). The angled struts of each cell function as a mechanism forrotating the fibers of the skirt in the same direction of the struts,allowing the skirt to elongate along the length of the struts. Thisallows for greater elongation of the skirt and avoids undesirabledeformation of the struts when the prosthetic valve is crimped.

In addition, the spacing between the woven fibers or yarns can beincreased to facilitate elongation of the skirt in the axial direction.For example, for a PET inner skirt 16 formed from 20-denier yarn, theyarn density can be about 15% to about 30% lower than in a typical PETskirt. In some examples, the yarn spacing of the inner skirt 16 can befrom about 60 yarns per cm (about 155 yarns per inch) to about 70 yarnsper cm (about 180 yarns per inch), such as about 63 yarns per cm (about160 yarns per inch), whereas in a typical PET skirt the yarn spacing canbe from about 85 yarns per cm (about 217 yarns per inch) to about 97yarns per cm (about 247 yarns per inch). The oblique edges 86, 88promote a uniform and even distribution of the fabric material alonginner circumference of the frame during crimping so as to facilitateuniform crimping to the smallest possible diameter. Additionally,cutting diagonal sutures in a vertical manner may leave loose fringesalong the cut edges. The oblique edges 86, 88 help minimize this fromoccurring.

In alternative embodiments, the skirt can be formed from woven elasticfibers that can stretch in the axial direction during crimping of theprosthetic valve. The warp and weft fibers can run perpendicularly andparallel to the upper and lower edges of the skirt, or alternatively,they can extend at angles between 0 and 90 degrees relative to the upperand lower edges of the skirt, as described above.

The inner skirt 16 can be sutured to the frame 12 at locations away fromthe suture line 154 so that the skirt can be more pliable in that area.This configuration can avoid stress concentrations at the suture line154, which attaches the lower edges of the leaflets to the inner skirt16.

As noted above, the leaflet structure 14 in the illustrated embodimentincludes three flexible leaflets 41 (although a greater or a smallernumber of leaflets can be used). Additional information regarding theleaflets, as well as additional information regarding skirt material,can be found, for example, in U.S. patent application Ser. No.14/704,861, filed May 5, 2015, which is incorporated by reference in itsentirety.

The leaflets 41 can be secured to one another at their adjacent sides toform commissures 122 of the leaflet structure. A plurality of flexibleconnectors 124 (one of which is shown in FIG. 17) can be used tointerconnect pairs of adjacent sides of the leaflets and to connect theleaflets to the commissure window frame portions 30 (FIG. 5).

FIG. 17 shows the adjacent sides of two leaflets 41 interconnected by aflexible connector 124. Three leaflets 41 can be secured to each otherside-to-side using three flexible connectors 124, as shown in FIG. 18.Additional information regarding connecting the leaflets to each other,as well as connecting the leaflets to the frame, can be found, forexample, in U.S. Patent Application Publication No. 2012/0123529, whichis incorporated by reference herein in its entirety.

As noted above, the inner skirt 16 can be used to assist in suturing theleaflet structure 14 to the frame. The inner skirt 16 can have anundulating temporary marking suture to guide the attachment of the loweredges of each leaflet 41. The inner skirt 16 itself can be sutured tothe struts of the frame 12 using sutures 70, as noted above, beforesecuring the leaflet structure 14 to the skirt 16. The struts thatintersect the marking suture desirably are not attached to the innerskirt 16. This allows the inner skirt 16 to be more pliable in the areasnot secured to the frame and minimizes stress concentrations along thesuture line that secures the lower edges of the leaflets to the skirt.As noted above, when the skirt is secured to the frame, the fibers 78,80 of the skirt (see FIG. 12) generally align with the angled struts ofthe frame to promote uniform crimping and expansion of the frame.

FIG. 19 shows one specific approach for securing the commissure portions122 of the leaflet structure 14 to the commissure window frame portions30 of the frame. In this approach, the flexible connector 124 (FIG. 18)securing two adjacent sides of two leaflets is folded widthwise and theupper tab portions 112 are folded downwardly against the flexibleconnector. Each upper tab portion 112 is creased lengthwise (vertically)to assume an L-shape having an inner portion 142 folded against theinner surface of the leaflet and an outer portion 144 folded against theconnector 124. The outer portion 144 can then be sutured to theconnector 124 along a suture line 146. Next, the commissure tab assemblyis inserted through the commissure window 20 of a corresponding windowframe portion 30, and the folds outside of the window frame portion 30can be sutured to portions 144.

FIG. 19 also shows that the folded down upper tab portions 112 can forma double layer of leaflet material at the commissures. The innerportions 142 of the upper tab portions 112 are positioned flat againstlayers of the two leaflets 41 forming the commissures, such that eachcommissure comprises four layers of leaflet material just inside of thewindow frames 30. This four-layered portion of the commissures can bemore resistant to bending, or articulating, than the portion of theleaflets 41 just radially inward from the relatively more-rigidfour-layered portion. This causes the leaflets 41 to articulateprimarily at inner edges 143 of the folded-down inner portions 142 inresponse to blood flowing through the prosthetic valve during operationwithin the body, as opposed to articulating about or proximal to theaxial struts of the window frames 30. Because the leaflets articulate ata location spaced radially inwardly from the window frames 30, theleaflets can avoid contact with and damage from the frame. However,under high forces, the four layered portion of the commissures can splayapart about a longitudinal axis adjacent to the window frame 30, witheach inner portion 142 folding out against the respective outer portion144. For example, this can occur when the prosthetic valve 10 iscompressed and mounted onto a delivery shaft, allowing for a smallercrimped diameter. The four-layered portion of the commissures can alsosplay apart about the longitudinal axis when the balloon catheter isinflated during expansion of the prosthetic valve, which can relievesome of the pressure on the commissures caused by the balloon, reducingpotential damage to the commissures during expansion.

After all three commissure tab assemblies are secured to respectivewindow frame portions 30, the lower edges of the leaflets 41 between thecommissure tab assemblies can be sutured to the inner skirt 16. Forexample, as shown in FIG. 20, each leaflet 41 can be sutured to theinner skirt 16 along suture line 154 using, for example, Ethibond Excel®PET thread. The sutures can be in-and-out sutures extending through eachleaflet 41, the inner skirt 16, and each reinforcing strip 72. Eachleaflet 41 and respective reinforcing strip 72 can be sewn separately tothe inner skirt 16. In this manner, the lower edges of the leaflets aresecured to the frame 12 via the inner skirt 16. As shown in FIG. 20, theleaflets can be further secured to the skirt with blanket sutures 156that extend through each reinforcing strip 72, leaflet 41 and the innerskirt 16 while looping around the edges of the reinforcing strips 72 andleaflets 41. The blanket sutures 156 can be formed from PTFE suturematerial. FIG. 21 shows a side view of the frame 12, leaflet structure14 and the inner skirt 16 after securing the leaflet structure 14 andthe inner skirt 16 to the frame 12 and the leaflet structure 14 to theinner skirt 16.

FIGS. 22-23 show another embodiment of an outer skirt or sealing member200 that can be incorporated in a prosthetic valve, such as valve 10.FIG. 22 shows a flattened view of the outer skirt 200 prior to itsattachment to a prosthetic heart valve. FIG. 23 shows a view of theouter skirt 200 in a cylindrical configuration prior to its attachmentto a prosthetic heart valve.

Referring to FIGS. 22-23, the outer skirt 200 can comprise an upper edgeportion 202, a lower edge portion 204 and an intermediate portion 206disposed between the upper edge portion 202 and the lower edge portion204. The intermediate portion 206 can comprise a plurality of verticalslits, cuts, or openings 208 cut or otherwise formed in the outer skirt200 at circumferentially spaced apart locations. Each adjacent pair ofslits 208 defines a vertical strip 210 (also referred to as a skirtsegment) therebetween such that there are a plurality of such strips210, each extending lengthwise along the length of the outer skirt 200from the upper edge portion 202 to the lower edge portion 204. Eachstrip 210 in the illustrated embodiment defines opposing longitudinallyextending edge portions 212 adjacent to respective slits 208.

The outer skirt 200 can be formed from synthetic materials, includingwoven fabrics, non-woven fabrics, or non-fabric materials (e.g., foams,sheets), formed from any of various suitable biocompatible polymer, suchas PET, PTFE, ePTFE, polyurethane, polyester; natural tissue(pericardium); and/or other suitable materials configured to restrictand/or prevent blood-flow therethrough. Alternatively, the outer skirt200 can be formed from an elastic material. The slits 208 can be lasercut or formed by any other suitable means. The outer skirt 200 can besecured to the frame of a prosthetic heart valve as discussed below inconnection with FIGS. 24-25.

The slits 208 in the illustrated embodiment are straight, and thereforedefine strips 210 that are rectangular. However, in other embodiments,the slits 208 can have various other shapes, including curved portions,so as to define strips 210 of various shapes. For example, the slits 208can have an undulating or sinusoidal shape so as to define strips 210having longitudinal side edges of the same shape. Further, as shown inthe illustrated embodiment, the slits 208 terminate short of the upperand lower edges of the skirt. As such, the strips 210 are connected toeach other at their upper and lower ends by the upper edge portion 202and the lower edge portion 204 of the skirt. In other embodiments, oneor more of the slits 208 can extend all the way to the very upper orlower edge of the skirt such that a strip 210 is not connected to anadjacent strip where the slit 208 extends all the way to an upper orlower edge of the skirt.

FIGS. 24-25 show the outer skirt 200 of FIGS. 22-23 mounted on theoutside of a frame 12. FIG. 25 shows an enlarged view of a portion ofthe frame 12 and the outer skirt 200. The frame 12 and the outer skirt200 can be part of a prosthetic heart valve similar to prosthetic heartvalve 10 that can include a valvular structure similar to valvularstructure 14 and an inner skirt similar to inner skirt 16, as best shownin FIGS. 1-3. For illustrative purposes, FIGS. 24-25 only show the frame12 and the outer skirt 200.

As previously described and as best shown in FIG. 5, the frame 12comprises axially extending struts 34 between rows I and II of angledstruts 22, 24. The first row of struts I, the second row of struts IIand the axially extending struts 34 define a plurality of cells definingopenings 36. Prior to attachment to the frame 12, the outer skirt 200can be arranged around the outer surface of the frame 12 such that eachslit 208 is adjacent to an axially extending strut 34 and such that eachstrip 210 substantially covers one of the cell openings 36. The upperand lower edge portions 202, 204 of the outer skirt 200 can be securedto the frame 212 using suitable techniques and/or mechanisms, includingsutures, an adhesive and/or ultrasonic welding. In particularembodiments, for example, the entire extent of the lower edge portion204 can be sutured to the angled struts 22 of row I of the frame 12,while the upper edge portion 202 can be sutured at the junctions formedby the intersection of struts 26 with struts 28. In other embodiments,the entire extent of the upper edge portion 202 can be sutured to struts26 or struts 28. In some embodiments, the upper edge portion 202 canhave an undulating or scalloped shaped, such as shown for the skirt 18and can be sutured to the frame 12 as shown in FIG. 1.

In particular embodiments, the height H of the outer skirt 200 in theaxial direction can be greater than the axial distance between theattachment locations of the upper and lower edge portions 202, 204 ofthe outer skirt 200 when the frame 12 is in a radially collapsedconfiguration. In this manner, radial expansion of the frame 12 resultsin foreshortening of the frame 12 between the attachment locations ofthe skirt 200, creating slack in the skirt 200 between the attachmentslocations and allowing the strips 210 to move outwardly from the frame12. In the illustrated example, the axial length of the outer skirt 200is equal to the length of a strut 22 plus the length of a strut 34 plusthe length of a strut 24 plus the length of a strut 26 of frame 12. Inalternative embodiments, the outer skirt 200 can have different heightsH, depending on the particular application.

In addition to the upper and lower end portions 202, 204 being securedto the frame 12, at least one of the longitudinal edge portions 212 ofeach of the plurality of strips 210 can be secured to the frame 12and/or to other strips so as to produce circumferential and/or twistingmovement of the strips 210 upon radial expansion of the frame 12. In theillustrated example, the strips 210 are secured to the frame 12 withtethers 214, which can be, for example, sutures, flexible wires,filaments, or similar materials. Alternatively, the strips 210 can besecured to the frame 12 with adhesive and/or ultrasonic welding inaddition to or in lieu of sutures.

In the illustrated embodiment, for each one of the plurality of strips210, an edge portion 212 a can be secured to a strut 34 with a tether214 having one end 214 a tied off or knotted around the strut 34 and theother end 214 b tied off to the strip 212. Desirably, the edge 212 a ofthe strip 210 is secured to the strut 34 that is closest to theunsecured edge 212 b of the same strip such that the tether 214 extendsacross the width of the strip 210 and the unsecured edge 212 b. As such,when the frame 12 is in a radially collapsed configuration, the axiallyextending struts 34 are closer together and the strips 210 extend in asubstantially straight line between the upper and lower edges 202, 204of the skirt 200. However, when the frame 12 expands to a radiallyexpanded configuration, the axially extending struts 34 move away fromeach other, pulling the secured edge 212 a of each strip 210 toward itsunsecured edge 212 b, thereby decreasing the width of the strip 210between its upper and lower ends (the width of the strip extending inthe circumferential direction) and forming longitudinal folds in thestrip 210. In this manner, the strips 210 form rib-like projections thatcan also extend radially outward from frame 12 due to the foreshorteningof the frame 12 as it expands radially.

In the illustrated embodiment, the tethers 214 are positioned radiallyoutside of the skirt 200. In some embodiments, the tethers 214 can bepositioned radially inside of the skirt 200. In other embodiments, someof the tethers 214 can be positioned outside of the skirt 200 whileother tethers 214 are positioned inside of the skirt 200. When theprosthetic valve (e.g., a valve 10 with outer skirt 200) is implanted ina native annulus, the projections formed by the strips 210 can contactand form a seal against the surrounding tissue to prevent or minimizeperivalvular leakage.

FIGS. 26-27 show another embodiment comprising a frame 12 and an outerskirt 200. The embodiment of FIGS. 26-27 is the same as the embodimentof FIGS. 24-25 except for the manner in which the skirt 200 is securedto the frame 12. As noted above with respect to the embodiment of FIGS.24-25, the embodiment of FIGS. 26-27 can include a valvular structure,such as valvular structure 14, and an inner skirt, such as inner skirt16, as best shown in FIGS. 1-3, to form a prosthetic heart valve. Forillustrative purposes, FIGS. 26-27 only show the frame 12 and the outerskirt 200.

Referring to FIGS. 26-27, the upper and lower edge portions 202, 204 ofthe outer skirt 200 can be secured to the frame 12 as previouslydescribed herein. A first longitudinal edge portion 212 a of each strip210 can be secured to a strut 34 a that is adjacent to a secondlongitudinal edge portion 212 b of the same strip 210 by a first tether214. The first tether 214 extends across the width of the strip 210 andhas a first end 214 a tied off or knotted around the strut 34 a and asecond end 214 b that is secured to the edge portion 212 a. The secondlongitudinal edge portion 212 b is secured to a strut 34 b that isadjacent the first edge portion 212 a by a second tether 216. The secondtether 216 extends across the width of the strip and has a first end 216a tied off or knotted around the strut 34 b and a second end 216 bsecured to the second edge portion 212 b.

The tethers 214, 216 desirably are on opposite sides of the skirt 200.As shown in the illustrated embodiment, the first tether 214 ispositioned radially outside of the skirt 200, while the second tether216 is positioned radially inside of the skirt 200. As such, when theframe 12 expands to a radially expanded configuration (causing struts 34a, 34 b to move away from each other), the first edge portion 212 a ispulled toward the second edge portion 212 b by the first tether 214 andthe second edge portion 212 b is pulled toward the first edge portion212 a. The pulling of the tethers 214, 216 causes the width of the strip210 to decrease and form longitudinal folds, and also causes the strip210 to become slightly twisted or rotated by virtue of the tethers 214,216 being on opposite sides of the outer skirt 200. As previouslydescribed, the strips 210 can also project radially away from the frame12 due to frame foreshortening, forming rib-like projections that canhelp seal the prosthetic valve against the native annulus. Inalternative embodiments, the tethers 214, 216 can be on the same side ofthe skirt 200 (i.e., both tethers 214, 216 can be positioned radiallyoutside the skirt 200 or radially inside the skirt 200), in which casethe strip 210 assumes a similar shape upon expansion of the frame butwithout twisting of the opposing edge portions 212 a, 212 b.

FIGS. 28-29 show another embodiment comprising a frame 12 and an outerskirt 200. The embodiment of FIGS. 28-29 is the same as the embodimentof FIGS. 24-25 except for the manner in which the skirt 200 is securedto the frame 12. As noted above with respect to the embodiment of FIGS.24-25, the embodiment of FIGS. 28-29 can include a valvular structure,such as valvular structure 14, and an inner skirt, such as inner skirt16, as best shown in FIGS. 1-3, to form a prosthetic heart valve. Forillustrative purposes, FIGS. 28-29 only show the frame 12 and the outerskirt 200. In this embodiment, the skirt segments are coupled to eachother with tethers (rather than to struts of the frame) to producemovement of the skirt segments upon radial expansion of the frame.

Referring to FIGS. 28-29, the upper and lower edge portions 202, 204 ofthe outer skirt 200 can be secured to the frame 12 as previouslydescribed herein. The outer skirt 200 comprises a plurality of strips210 a and 210 b alternately positioned around an outer surface of theframe 12, which are similar to the strips 210 of FIGS. 24-25 except forhow they are secured to the frame 12. A first longitudinal edge portion212 a of each strip 210 a can be secured to a longitudinal edge portion212 c of an adjacent strip 210 b by a first tether 218. The first tether218 can extend across the width of strips 210 a and 210 b and can have afirst end 218 a secured to the edge portion 212 c and a second end 218 bsecured to the edge portion 212 a. A second longitudinal edge portion212 b of each strip 210 a can be secured to a longitudinal edge portion212 d of an adjacent strip 210 b on the other side of the strip 210 a bya second tether 220. The second tether 220 can extend across the widthof strips 210 a and 210 b and can have a first end 220 a secured to theedge portion 212 b and a second end 220 b secured to the edge portion212 d. In this manner, each strip 210 a is coupled to two strips 210 bon opposite sides of the strip 210 a by tethers 218, 220. Each strip 210b can be coupled to two strips 210 a in the same manner.

The tethers 218, 220 desirably are on opposite sides of the skirt 200.As shown in the illustrated embodiment, the first tether 218 ispositioned radially inside of the skirt 200, while the second tether 220is positioned radially outside of the skirt 200. As such, when the frame12 expands to a radially expanded configuration, the edge portions 212a, 212 c of strips 210 a, 210 b, respectively, are pulled inwardlytowards each other and the edge portions 212 b, 212 d of strips 210 a,210 b, respectively, are pulled outwardly towards each other. Thepulling of strips 210 a, 210 b causes the width of the strips 210 a, 210b to decrease and form longitudinal folds, and also causes the strips210 a, 210 b to become slightly twisted or rotated by virtue of thetethers 218, 220 being on opposite sides of the outer skirt 200. Aspreviously described, the strips 210 a, 210 b can also project radiallyaway from the frame 12 due to frame foreshortening, forming rib-likeprojections that can help seal the prosthetic valve against the nativeannulus. In alternative embodiments, the tethers 218, 220 can be on thesame side of the skirt 200 (i.e., both tethers 2184, 220 can bepositioned radially outside the skirt 200 or radially inside the skirt200), in which case the strips 210 a, 210 b assume a similar shape uponexpansion of the frame but without twisting of the opposing edgeportions 212 a, 212 b, 212 c, 212 d.

In the embodiment of FIGS. 28-29, each edge portion of a strip iscoupled to the farthest edge portion of an adjacent strip. Inalternative embodiments, each edge portion of a strip can be coupled tothe closer edge portion of an adjacent strip. For example, edge portion212 a of a strip 210 a can be coupled to edge portion 212 d of one strip210 b by tether 218, while edge portion 212 b can be coupled to edgeportion 212 c by tether 220 of another strip 210 b. In still otherembodiments, the different techniques for coupling the skirt strips tothe frame struts and to each other described above can be combined in asingle prosthetic valve. For example, a skirt 200 can have some stripscoupled to frame struts in the manner shown in FIGS. 24-25, some stripscoupled to frame struts in the manner shown in FIGS. 26-27, and somestrips coupled to each other in the manner shown in FIGS. 28-29 and/ordescribed above.

In alternative embodiments, instead of having a single skirt mounted onthe outside of the frame, the outer sealing member can comprise aplurality of discrete sealing segments positioned side-by-side aroundthe circumference of the frame. For example, instead of cutting slits208 in the skirt 200, the skirt 200 can be cut along cut lines extendingfrom the lower edge to the upper edge at the locations of slits 208 inFIG. 22 to form a plurality of rectangular sealing segments. Eachdiscrete sealing segment can be secured to the frame at its upper andlower edge portions. Each discrete sealing segment can be coupled to theframe and/or to one or more other sealing segments by one or moretethers using any of the configurations described above.

The prosthetic valve 10 can be configured for and mounted on a suitabledelivery apparatus for implantation in a patient. Several catheter-baseddelivery apparatuses can be used; a non-limiting example of a suitablecatheter-based delivery apparatus includes that disclosed in U.S. PatentApplication Publication No. 2013/0030519, which is incorporated byreference herein in its entirety, and U.S. Patent ApplicationPublication No. 2012/0123529.

In one example, to implant a plastically-expandable prosthetic valve 10within a patient, the prosthetic valve 10, including the frame 12 andthe outer skirt 200 can be crimped on an elongated shaft 180 of adelivery apparatus, as best shown in FIG. 13. The prosthetic valve,together with the delivery apparatus, can form a delivery assembly forimplanting the prosthetic valve 10 in a patient's body. The shaft 180comprises an inflatable balloon 182 for expanding the prosthetic valvewithin the body. With the balloon 182 deflated, the prosthetic valve 10can then be percutaneously delivered to a desired implantation location(e.g., a native aortic valve region). Once the prosthetic valve 10 isdelivered to the implantation site (e.g., the native aortic valve)inside the body, the prosthetic valve 10 can be radially expanded to itsfunctional state by inflating the balloon 182.

Alternatively, a self-expanding prosthetic valve 10 can be crimped to aradially collapsed configuration and restrained in the collapsedconfiguration by inserting the prosthetic valve 10, including the frame12 and the outer skirt 200 into a sheath or equivalent mechanism of adelivery catheter. The prosthetic valve 10 can then be percutaneouslydelivered to a desired implantation location. Once inside the body, theprosthetic valve 10 can be advanced from the delivery sheath, whichallows the prosthetic valve 10 to expand to its functional state.

FIGS. 30-32 and 35 show various implantation positions for a prostheticheart valve 10 having outer skirt 200 in place of outer skirt 18 asdiscussed above in connection with FIGS. 24-29, including implantationwithin a dock or anchor placed inside the patient's body prior to valveimplantation. In the illustrated embodiments of FIGS. 30-31, the outerskirt 200 is configured in a manner described in connection with FIGS.24-25. In other embodiments, the outer skirt 200 of FIGS. 30-31 can beconfigured in a manner described in connection with FIGS. 26-27 or in amanner described in connection with FIGS. 28-29. FIG. 30 shows theprosthetic heart valve 10 implanted in the native aortic valve of apatient.

FIG. 31 shows the prosthetic heart valve 10 implanted in the pulmonaryartery of a patient for replacing or enhancing the function of adiseased pulmonary valve. Due to the variations in the size and shape ofthe native pulmonary valve and the pulmonary artery, the prostheticvalve 10 can be implanted within a radially expandable outer dockingdevice 300. The docking device 300 can comprise a radially expandableand compressible annular stent 302 and a sealing member 304 that coversall or a portion of the stent and can extend across the inner surfaceand/or outer surface of the stent. The docking device 300 is configuredto engage the inner wall of the pulmonary artery and can accommodatevariations in patient anatomy. The docking device 300 also cancompensate for the expanded prosthetic heart valve 310 being muchsmaller than vessel in which it is placed. The docking device 300 alsocan be used to support a prosthetic valve in other areas of thepatient's anatomy, such as, the inferior vena cava, superior vena cava,or the aorta. Further details of the docking device 300 and methods forimplanting the docking device and a prosthetic valve are disclosed, forexample, in co-pending U.S. application Ser. No. 15/422,354, filed Feb.1, 2017, which is incorporated herein by reference in its entirety.

FIG. 32 shows the prosthetic heart valve 10 implanted in the nativemitral valve of a patient using a docking device in the form of ahelical anchor 400. The helical anchor 400 can include one or more coils402 deployed in left atrium and one or more coils 404 deployed in theleft ventricle and radially outside of the native mitral valve leaflets406. When the prosthetic valve 10 is deployed within the native valve,the native leaflets are compressed or pinched between the prostheticvalve 410 and the anchor 400 to retain the prosthetic valve in place.Further details of the helical anchor 400 and methods for implanting theanchor and a prosthetic valve are disclosed, for example, in co-pendingU.S. Application No. 62/395,940, filed Sep. 16, 2016, which isincorporated herein by reference in its entirety.

FIGS. 33 and 34 show a docking device 500 for a prosthetic heart valve,according to another embodiment. The docking device 500 can include aradially expandable and compressible frame 502 having an outer portion504, an inner portion 506 disposed coaxially within one end portion ofthe outer portion 504, and a curved transition portion 508 extendingbetween and connecting the inner portion 506 and the outer portion 504.The docking device 500 can further include a sealing member 510extending over the inner surface of the inner portion 506, a portion ofthe outer surface of the outer portion 504 adjacent the inner portion506, and the transition portion 508.

FIG. 35 shows the docking device 500 implanted in a vessel 520, whichcan be, for example, the inferior vena cava, superior vena cava, or theascending aorta. As shown, a prosthetic valve 10 can be deployed withinthe inner portion 506 of the docking device 500. Similar to the dockingdevice 300, the docking device 500 can compensate for the expandedprosthetic heart valve 10 being much smaller than vessel in which it isplaced. The docking device 500 is particularly suited for implanting aprosthetic valve in the inferior vena cava for replacing or enhancingthe function of the native tricuspid valve. Further details of thedocking device 500 and methods for implanting the docking device and aprosthetic valve are disclosed, for example, in co-pending U.S.application Ser. No. 16/034,794, filed Jul. 13, 2018, which isincorporated herein by reference.

General Considerations

It should be understood that the disclosed valves can be implanted inany of the native annuluses of the heart (e.g., the pulmonary, mitral,and tricuspid annuluses), and can be used with any of various approaches(e.g., retrograde, antegrade, transseptal, transventricular,transatrial, etc.). The disclosed prostheses can also be implanted inother lumens of the body.

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedisclosed methods, apparatus, and systems should not be construed asbeing limiting in any way. Instead, the present disclosure is directedtoward all novel and nonobvious features and aspects of the variousdisclosed embodiments, alone and in various combinations andsub-combinations with one another. The methods, apparatus, and systemsare not limited to any specific aspect or feature or combinationthereof, nor do the disclosed embodiments require that any one or morespecific advantages be present or problems be solved.

Although the operations of some of the disclosed embodiments aredescribed in a particular, sequential order for convenient presentation,it should be understood that this manner of description encompassesrearrangement, unless a particular ordering is required by specificlanguage set forth below. For example, operations described sequentiallymay in some cases be rearranged or performed concurrently. Moreover, forthe sake of simplicity, the attached figures may not show the variousways in which the disclosed methods can be used in conjunction withother methods.

As used in this application and in the claims, the singular forms “a,”“an,” and “the” include the plural forms unless the context clearlydictates otherwise. Additionally, the term “includes” means “comprises.”

As used herein, the term “and/or” used between the last two of a list ofelements means any one or more of the listed elements. For example, thephrase “A, B, and/or C” means “A”, “B”, “C”, “A and B”, “A and C”, “Band C”, or “A, B, and C”.

As used herein, the term “proximal” refers to a position, direction, orportion of a device that is closer to the user and further away from theimplantation site. As used herein, the term “distal” refers to aposition, direction, or portion of a device that is further away fromthe user and closer to the implantation site. Thus, for example,proximal motion of a device is motion of the device toward the user,while distal motion of the device is motion of the device away from theuser. The terms “longitudinal” and “axial” refer to an axis extending inthe proximal and distal directions, unless otherwise expressly defined.

As used herein, the terms “coupled” and “associated” generally meanphysically coupled or linked and does not exclude the presence ofintermediate elements between the coupled or associated items absentspecific contrary language.

As used herein, operations that occur “simultaneously” or “concurrently”occur generally at the same time as one another, although delays in theoccurrence of one operation relative to the other due to, for example,spacing, play or backlash between components in a mechanical linkagesuch as threads, gears, etc., are expressly within the scope of theabove terms, absent specific contrary language.

In view of the many possible embodiments to which the principlesdisclosed herein may be applied, it should be recognized that theillustrated embodiments are only preferred examples and should not betaken as limiting the scope of the disclosure. Rather, the scope of thedisclosure is at least as broad as the following claims.

We claim:
 1. An implantable prosthetic valve comprising: an annularframe comprising an inflow end and an outflow end and being radiallycollapsible and expandable between a radially collapsed configurationand a radially expanded configuration, the frame defining an axialdirection extending from the inflow end to the outflow end; a leafletstructure positioned within the frame and secured thereto; and an outersealing member positioned around an outer surface of the frame, whereinthe outer sealing member comprises a plurality of sealing segments;wherein each sealing segment is coupled to the frame and/or anothersealing segment by a tether that pulls a portion of the sealing segmentin a circumferential direction when the frame is radially expanded tothe expanded configuration.
 2. The prosthetic valve of claim 1, whereineach sealing segment has upper and lower portions connected to the frameat axially spaced apart locations on the frame that move toward eachother upon radial expansion of the frame and cause a portion of thesealing segment to move radially outwardly away from the frame.
 3. Theprosthetic valve of claim 1, wherein the plurality of sealing segmentsare formed by a plurality of circumferentially spaced apart slits in theouter sealing member and wherein the plurality of sealing segments areconnected to each other at upper and lower ends by an upper edge portionand a lower edge portion of the outer sealing member.
 4. The prostheticvalve of claim 1, wherein the plurality of sealing segments are discretesealing segments that are positioned side-by-side around a circumferenceof the frame.
 5. The prosthetic valve of claim 1, wherein a width ofeach sealing segment in the circumferential direction is reduced by apulling force of the tether connected to the sealing segment upon radialexpansion of the frame.
 6. The prosthetic valve of claim 1, wherein eachsealing segment becomes at least partially twisted by a pulling force ofthe tether connected to the sealing segment upon radial expansion of theframe.
 7. The prosthetic valve of claim 1, wherein the tether has afirst end secured to the sealing segment and a second end secured to theframe or another sealing segment of the plurality of sealing segments.8. The prosthetic valve of claim 7, wherein the first end of the tetheris secured to a first longitudinal edge portion of the sealing segmentand the second end of the tether is secured to a strut of the frame thatis arranged closest to an opposing, second longitudinal edge portion ofthe sealing segment.
 9. The prosthetic valve of claim 1, wherein thetether is a first tether and wherein each sealing segment is furthercoupled to the frame and/or another sealing segment by a second tether.10. The prosthetic valve of claim 9, wherein a first end of the firsttether is secured to a first longitudinal edge portion of the sealingsegment and a second end of the first tether is secured to a first strutof the frame that is arranged adjacent to an opposing, secondlongitudinal edge portion of the sealing segment, wherein a first end ofthe second tether is secured to the second longitudinal edge portion ofthe sealing segment and a second end of the second tether is secured toa second strut of the frame that is arranged adjacent to the firstlongitudinal edge portion of the sealing segment, and wherein the firststrut and the second strut are axially extending struts of the frame andform a portion of a same cell of the frame.
 11. The prosthetic valve ofclaim 9, wherein each sealing segment is arranged adjacent to andbetween, in the circumferential direction, a first adjacent sealingsegment and a second adjacent sealing segment of the plurality ofsealing segments and wherein the sealing segment is coupled to the firstadjacent sealing segment by the first tether and coupled to the secondadjacent sealing segment by the second tether, wherein each of the firsttether and the second tether extends across a width of the sealingsegment, the width arranged in the circumferential direction.
 12. Theprosthetic valve of claim 11, wherein a first end of the first tether issecured to a first longitudinal edge portion of the sealing segment anda second end of the first tether is secured to a second longitudinaledge portion of the first adjacent sealing segment and wherein a firstend of the second tether is secured to a second longitudinal edgeportion of the sealing segment and a second end of the second tether issecured to a first longitudinal edge portion of the second adjacentsealing segment.
 13. An implantable prosthetic valve comprising: anannular frame comprising an inflow end and an outflow end and beingradially collapsible and expandable between a radially collapsedconfiguration and a radially expanded configuration, the frame definingan axial direction extending from the inflow end to the outflow end; aleaflet structure positioned within the frame and secured thereto; andan outer sealing member positioned around an outer surface of the frame,wherein the outer sealing member comprises a plurality of sealingsegments; wherein each sealing segment is coupled to the frame and/oranother sealing segment by a first tether that pulls a firstlongitudinal edge portion of the sealing segment in a firstcircumferential direction and a second tether that pulls a secondlongitudinal edge portion of the sealing segment in a secondcircumferential direction, when the frame is radially expanded to theexpanded configuration.
 14. The implantable prosthetic valve of claim13, wherein, for each sealing segment, the first tether is secured tothe first longitudinal edge portion of the sealing segment and a firststrut of the frame that is arranged adjacent to the second longitudinaledge portion of the sealing segment and the second tether is secured tothe second longitudinal edge portion and a second strut that is arrangedadjacent to the first longitudinal edge portion.
 15. The implantableprosthetic valve of claim 13, wherein, for each sealing segment, thefirst tether is secured to the first longitudinal edge portion of thesealing segment and a second longitudinal edge portion of a firstadjacent sealing segment of the plurality of sealing segments and thesecond tether is secured to the second longitudinal edge portion of thesealing segment and a first longitudinal edge portion of a secondadjacent sealing segment, wherein each of the first tether and thesecond tether extend across a width of the sealing segment, the widtharranged in the first and second circumferential directions.
 16. Theimplantable prosthetic valve of claim 13, wherein, for each sealingsegment, the first tether and the second tether are configured to reducea width of a portion of the sealing segment arranged between an upperedge portion and a lower edge portion of the outer sealing member andcreate longitudinal folds in the sealing segment.
 17. The implantableprosthetic valve of claim 13, wherein the first tether is positionedradially inside of the outer sealing member and the second tether ispositioned radially outside of the outer sealing member, relative to aradial direction that is arranged perpendicular to the axial direction.18. An implantable prosthetic valve comprising: an annular framecomprising an inflow end and an outflow end and being radiallycollapsible and expandable between a radially collapsed configurationand a radially expanded configuration, the frame defining an axialdirection extending from the inflow end to the outflow end; a leafletstructure positioned within the frame and secured thereto; and an outersealing member positioned around an outer surface of the frame, whereinthe outer sealing member comprises a plurality of sealing segments,wherein each sealing segment extends longitudinally, in the axialdirection, between an upper edge portion and a lower edge portion of theouter sealing member and has a width defined between a firstlongitudinal edge portion and a second longitudinal edge of the sealingsegment; and wherein each sealing segment is coupled to the frame and/oranother sealing segment by at least a first tether that pulls a portionof the sealing segment in a circumferential direction such that thewidth of the sealing segment between its upper and lower ends decreasesand forms longitudinal folds in the sealing segment when the frame isradially expanded to the expanded configuration, wherein the portion ofthe sealing segment is one of the first longitudinal edge portion andthe second longitudinal edge portion of the sealing segment.
 19. Theimplantable prosthetic valve of claim 18, wherein the first tether iscoupled to the first longitudinal edge portion of the sealing segmentand wherein each sealing segment is coupled to the frame and/or anothersealing segment by a second tether that pulls the second longitudinaledge portion of the sealing segment in the circumferential directionwhen the frame is radially expanded to the expanded configuration. 20.The implantable prosthetic valve of claim 19, wherein the first tetherand the second tether are arranged on opposite sides of the outersealing member, relative to a radial direction that is arrangedperpendicular to the axial direction and the width.